Improving Exercise Capacity With a Tailored Physical Activity Intervention

Quality of Life Clinical Trial

— PALS  

Official title:

Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595577
• Other study ID #: IRB00087763
• Secondary ID: 4R33CA226960-03W
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2024
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-758-3728
• Email: scnorton[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to test whether participating in either a physical activity intervention or a series of educational classes will help to preserve exercise capability, heart function, brain-based activities (like memory), and quality of life. Participants will be randomized to 1 of 2 pathways: - First pathway consists of organized health workshops. These workshops are intended to provide information on topics such as proper nutrition, management of stress, sleep practices, and emphasis on a healthy lifestyle that may help the participants through cancer treatment. This pathway will also test whether stretching may help participants through cancer treatment. - Second pathway participants will take part in some unsupervised and some potentially supervised moderate activity sessions each week throughout participants' cancer treatment to take place either remotely or in person, depending on availability of facilities at the time visits are scheduled.

Description:

Primary Objective: To determine if a >10% difference exists in the % change (i.e., 2.06 ml/kg/min difference) in peak VO2 (volume or amount of oxygen your body consume) from baseline to 6 months of intervention between participants receiving the Physical Activity Intervention (PAI) versus Healthy Living Intervention (HLI). Secondary Objectives: - To determine if a >10% difference exists in the % change in peak exercise cardiac output, calculated A-VO2 difference, and pre-exercise measures of left ventricular function from baseline to 6 months of intervention between participants receiving the PAI versus HLI. - Among these same participants, 1) to compare PAI and HLI groups on their baseline to 3 & 6 months after initiating cancer treatment changes in 6-minWD, Health-Related Quality of Life (HRQOL), fatigue, strength, physical activity, cognitive & physical function, 2) to determine the relationships between the 6-month time-dependent changes in these and peak VO2; and 3) to examine whether time-dependent changes in peak exercise cardiac output and/or calculated arteriovenous oxygen difference are associated with similar time-dependent changes in peak VO2. - Assess physical activity engagement via accelerometry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

To be considered eligible, participants must meet all of the following criteria:

• Individuals aged 18- 85 years
• Diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer
• Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab, rituximab]), immuno-therapies (immune checkpoint inhibitors [ICI's]) or radiation (within 8 weeks of completion of radiation).29-31
• Ability to speak and understand English
• Capacity to walk at least 2 city blocks (~.2 miles) on a flat surface
• Expected survival beyond 6 months.
• Must have an assistant that will help perform the home-based testing activities Exclusion Criteria:

If the patient meets any of these criteria they are excluded from the study:

• Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
• Recent history of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion (unless approved by the participant's physician and the Principal Investigator) NOTE: In the setting of active inflammation, participation will not be approved. If chronic disease is present and stable as judged by the participant's physician and the PI, participation will be approved.
• Contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices (unless approved by the participant's physician and the Principal Investigator)
• Pregnant
• Unstable angina
• Contraindication for exercise training or testing
• Inability to exercise on a treadmill or stationary cycle
• Significant ventricular arrhythmias (>20 PVCs/min due to gating difficulty)
• Atrial fibrillation with uncontrolled ventricular response
• Acute myocardial infarction within 28 days
• Inability to provide informed consent

Related Conditions & MeSH terms

• Breast Neoplasms
• Heart; Functional Disturbance
• Hodgkin Lymphoma
• Lymphoma
• Non Hodgkin Lymphoma
• Quality of Life
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage III Breast Cancer

Intervention

Other:
• Exercise with Trainerize application
1-2 sessions per week consisting of slow 15 minute aerobic warm, 20 minutes of strength training, 15 minutes progressive intensity aerobic exercise and 10 minute cool down (stretching/toning) with elastic bands.

Diagnostic Test:
• Cardiopulmonary exercise testing
Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test.
• MRI scan
Images of the heart will be taken.

Behavioral:
• Quality of Life Questionnaires
Participants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete.
• Cognitive and Brain Function Questionnaires
Participants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete.

Other:
• Blood draws
Approximately 2 teaspoons of blood withdrawn from either a vein in your arm or a currently placed central line port-a-cath. A portion of blood from each visit will be used to collect information about blood cell count.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak VO2	An analysis of covariance (ANCOVA) model will be used to assess post-intervention group differences in VO2, adjusted for baseline peak VO2.	At baseline and 6 months after study intervention
Secondary	Change in Peak Exercise Cardiac Output	Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.	At baseline and 6 months after study intervention
Secondary	Change in Calculated A-V Oxygen Levels	Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.	At baseline and 6 months after study intervention
Secondary	Changes in Measurements of Pre-exercise Left Ventricular Function	Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.	At baseline and 6 months after study intervention
Secondary	Change in Neurocognitive Function - Hopkins Verbal Learning Test	The Hopkins Verbal Learning Test (HVLT-R) consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall). This test has three parts and two alternate forms. Total scores could range from 0 to 30. Lower raw scores indicate difficulties with the task.	At baseline and 6 months after study intervention
Secondary	Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT)	The Controlled Oral Word Association Test is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). COWAT is measured by calculating the total number of acceptable words produced for at the given letter of the alphabet. Errors and perseverations (word repetitions) are not included in this score.	At baseline and 6 months after study intervention
Secondary	Change in Neurocognitive Function - Digit Span-Backward Test	The digit span backward test is used to assess working memory. Participants are given a series of digits and asked to repeat them backward. The item score is the sum of the scores on the two trials for that item (range=0-2). The total raw score for backwards digit span is the sum of the item scores; maximum backwards digit span total raw score is 16 points.	At baseline and 6 months after study intervention
Secondary	Change in Neurocognitive Function - Trail Making Test	The Trail Making Test (TMT) asks patients to connect consecutive "targets" (numbers and/or letters) on a page arranged in a specific geometric pattern. Scoring is based on time taken to complete the test (e.g. 35 seconds yielding a score of 35) with lower scores being better.	At baseline and 6 months after study intervention
Secondary	Change in 6-Minute Walk Distance	Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.	At baseline, 3 months and 6 months after study intervention
Secondary	Health-Related Quality of Life Questionnaire (FACT-Lym or FACT-B)	FACT-Lym is 42-item questionnaire to assess the quality of life for lymphoma patients. 5-point Likert scale - 0 (not at all) to 4 (very much). Subscale domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Lymphoma Subscale. Some items are reverse scored. Subscales scores are added to get the total score. The higher the score, the better the quality of life. Scores can range from 0-168.; FACT-B is a 37-item Functional Assessment of Cancer Therapy-Breast (FACT-B) that measures five domains of health-related quality of life in breast cancer patients. These include physical, social, emotional and functional well being on a Likert scale 0-4 with (not at all) to 4 (very much). The higher the score, the better quality of life. Scores can range from 0-148.	At baseline, 3 months and 6 months after study intervention
Secondary	Fatigue Questionnaire	Questionnaire to assess the difference in the level of fatigue participants experience will performing study interventions. 5-point Likert scale - 0 (not at all) to 4 (very much). The higher the score the higher level of fatigue participants experience. Score range 0-52.	At baseline, 3 months and 6 months after study intervention
Secondary	Change in Physical Activity Levels - Godin Leisure Time Exercise Questionnaire	The questionnaire is a 4-item measure used to classify participants' activity levels during a typical 7-day period based on how many times on average participants exercise more than 15 minutes during their free time of strenuous, moderate or mild exercise.	At baseline, 3 months and 6 months after study intervention
Secondary	Change in Physical Function - Balance Test	Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support: heel of one foot beside the big toe of the other foot (semi-tandem position), heel of one foot in front of and touching the toes of the other foot (tandem position), and single leg stand.	At baseline, 3 months and 6 months after study intervention
Secondary	Change in Physical Function - Chair Stand Test	The repeated chair stand test will be performed using a straight-backed chair placed with its back against a wall. Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded.	At baseline, 3 months and 6 months after study intervention
Secondary	Change in Physical Function - 4-Meter Walk Gait Speed Test	The gait speed test will assess the participant's ability to walk 4 meters. Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their usual speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded	At baseline, 3 months and 6 months after study intervention
Secondary	Change in Physical Function - Grip Strength	Grip strength will be assessed using an isometric handgrip dynamometer while the participant is seated with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position. The participant should exert maximally and quickly (about 1 second) and two trials should be made alternately with each hand, with at least 30 seconds between trials for the same hand (recorded in kilograms).	At baseline, 3 months and 6 months after study intervention